Disposable speculum having lateral stabilizing mechanism

ABSTRACT

A speculum includes upper and lower members and a linear support member. The upper member includes an upper blade. The lower member includes a lower blade and a handle portion. The lower blade includes a support structure at a proximal end thereof which extends vertically on the right or left side of the lower blade, and a handle portion extending downwardly from the lower blade and defining a vertical track. The linear support member has a proximal end pivotally connected to the upper blade, a distal end, and an elongated body between the proximal and distal ends. The elongated body slidably engages the vertical track of the handle portion. The linear support member is formed with a hidden slot which slidably receives the support structure of the lower blade.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/387,038 that was filed on Sep. 28, 2010. The entire content of thisprovisional application is hereby incorporated herein by reference.

FIELD

The embodiments disclosed herein relate to speculums, and moreparticularly to disposable vaginal speculums having lateral support andoperating mechanisms.

BACKGROUND

A speculum is a medical instrument for dilating the opening of a bodycavity for medical examination. A vaginal speculum commonly used duringa gynecological examination or a surgical procedure is introduced into apatient's vagina to separate the vaginal walls, thus allowing theinternal genital organs to be examined. Metal, autoclavable specula areconventionally used for gynecological examination and treatment. Theseunits, with exposed joints, sharp edges, and cold metal are universallydisliked by patients. The hinged joints and blade edges often pinch,scrape, or otherwise traumatize the supporting tissues in the area beingexamined. The conventional metallic specula blades are typically opaque.Therefore, the only area available for inspection when a metallicspeculum is in use is the open end, for cervical examination, and thevaginal wall areas between the blades.

In an attempt to eliminate some of the problems mentioned above, plasticspecula have been developed. Plastic specula, which are formed fromplastic or another lightweight and inexpensive material, are oftendesigned with a double-hinge. Although these double-hinge designssatisfactorily support the vertical stresses placed on the speculum,current designs allow for significant movement when exposed to lateralforces. Such lateral forces are common when vaginal muscles become tenseduring procedures which do not require anesthesia, and the resultinglateral movement is objectional to the physician because it can resultin speculum movement inside the vagina, or in the worst case speculumcollapse.

Sufficient lighting of the subject area for examination is another areaof difficulty, since typical specula are not equipped with illuminationdevices. Light must be directed from another source, often a goosenecklamp that can partially obstruct the view into the vagina. Head-mountedlights have been used as a partial solution to this problem, but suchhead-mounted lights are uncomfortable for the operator and cumbersomedue to the light cord. Lights built into the handle of existing speculagenerally project into a light pipe which follows up the center of thespeculum. Since this light and light pipe assembly occupy the center ofthe handle the speculum hinge mechanism must be offset to one side.However, such offsetting from the center of the speculum has theundesirable effect of increasing lateral movement resulting from stress.

SUMMARY

Accordingly, at least one exemplary embodiment may provide a speculum.The speculum according to this embodiment may comprise an upper member,a lower member, and a linear support member. The upper member comprisesan upper blade which has a distal end and a proximal end. The lowermember comprises a tower blade having a distal end and a proximal endand having a right side and a left side when viewed from the proximalend of the lower blade, the lower blade comprising a support structurepositioned at the proximal end of the tower blade and which extendsvertically on one of the right side or the left side of the lower blade.The lower member further comprises a handle portion extending downwardlyfrom the proximal end of the lower blade and defining a vertical track.The linear support member has a proximal end pivotally connected to theproximal end of the upper blade, a distal end, and an elongated bodybetween the proximal end and the distal end of the linear supportmember. The elongated body of the linear support member slidably engagesthe vertical track of the handle portion. The linear support member isformed with a hidden slot which slidably receives the support structureof the lower blade.

In another exemplary embodiment, a method for dilating a vagina may beprovided. The method according to this embodiment may comprise providinga disposable vaginal speculum. The disposable vaginal speculum comprisesan upper member, a lower member, and a linear support member. The uppermember comprises an upper blade which has a distal end and a proximalend. The lower member comprises a lower blade having a distal end and aproximal end and having a right side and a left side when viewed fromthe proximal end of the lower blade, the lower blade comprising asupport structure positioned at the proximal end of the lower blade andwhich extends vertically on one of the right side or the left side ofthe lower blade. The lower member further comprises a handle portionextending downwardly from the proximal end of the lower blade anddefining a vertical track. The linear support member has a proximal endpivotally connected to the proximal end of the upper blade, a distalend, and an elongated body between the proximal end and the distal endof the linear support member. The elongated body of the linear supportmember slidably engages the vertical track of the handle portion. Thelinear support member is formed with a hidden slot which slidablyreceives the support structure of the lower blade. The method fordilating a vagina according to this embodiment may further compriseinserting the upper blade and the lower blade of the speculum into anopening of the vagina, and creating a working space between the upperblade and the lower blade, thus dilating the vagina.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1A and FIG. 1B show an embodiment of a vaginal speculum of thepresent disclosure. FIG. 1A is a perspective view of the vaginalspeculum. FIG. 1B is a rear view of the vaginal speculum.

FIG. 2 is a perspective view of an upper member of the vaginal speculumof FIG. 1A.

FIG. 3 is a plan view showing an interior side of the upper member ofthe vaginal speculum of FIG. 2. The upper member includes an upperblade, a supporting structure, and an operating mechanism.

FIG. 4A and FIG. 4B are perspective views of a lower member of thevaginal speculum of FIG. 1A. FIG. 4A is a rear perspective view of thelower member. FIG. 4B is a front perspective view of the lower member.

FIG. 5 is a close-up plan view of the lower member of the vaginalspeculum of FIG. 4A and FIG. 4B. The lower member includes a lower bladeand a track for engaging a linear support member.

FIG. 6 is a close-up perspective view of the track of FIG. 5.

FIG. 7 is a perspective view of a linear support member of the vaginalspeculum of FIG. 1A and FIG. 1B.

FIG. 8A and FIG. 8B show the upper member of FIG. 1A and FIG. 1B securedto the linear support member of FIG. 7. FIG. 8A is a side view of theupper member secured to the linear support member. FIG. 8B is aperspective view of the upper member secured to the linear supportmember.

FIG. 9 is a perspective rear view of the linear support member of FIG. 7positioned within the track of the lower member of FIG. 6.

FIG. 10A, FIG. 10B and FIG. 10C show an embodiment of a light source foruse with the vaginal speculum of FIG. 1A and FIG. 1B. FIG. 10A is aperspective view of the light source showing some of the outer and theinner components. FIG. 10B is a back view of the light source showinginner components. FIG. 10C is a side view of the light source showingsome of the outer components.

FIG. 11 shows an embodiment of a light guide and smoke evacuationchannel for use with the vaginal speculum of FIG. 1A and FIG. 1B havingthe light source of FIG. 10A.

FIG. 12 shows a rear perspective view of the lower member of the vaginalspeculum of FIG. 1 having the light source of FIG. 10A.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Vaginal speculums having lateral stabilized support and operatingmechanisms are disclosed herein. The disclosed vaginal speculums arefabricated from plastic materials, and are designed to be for single-useand are fully disposable. Although the vaginal speculums disclosedherein are intended to be used by gynecologists, it is understood thatthe vaginal speculums may also be used for example, by primary carephysicians, geriatricians, urologists and nurse practitioners.

As used herein, the term “cross-contamination” refers to the passing ofbacteria or viruses indirectly from one patient to another through theuse of improper sterilization procedures, unclean instruments, orrecycling of products.

As used herein, the term “disposable” refers to a vaginal speculum ofthe present disclosure designed for short-term convenience, and intendedfor single-use. The disposable vaginal speculum therefore does not needto be sterilized after use, which reduces the cost of maintaining thevaginal speculum, and minimizes the risk of cross-contamination.

As used herein, the term “female internal genital organs” refers to thevulva, vagina and cervix.

As used herein, the term “gynecological examination” or “surgicalprocedure” refers to a medical procedure performed on a female patientto visualize, inspect, and/or remove a portion of the female internalgenital organs. Common gynecological procedures and surgeries include,but are not limited to, colposcopy, cervical cryosurgery, loopelectrosurgical excision procedure (LEEP) procedure, hysteroscopy,dilation and curettage (D&C), cervical biopsy, transcervical chorionicvillus sampling, endometrial ablation, endometrial biopsy, vaginalhysterectomy and PAP test.

The vaginal speculums disclosed herein can be used during variousmedical procedures, and more particularly are used for unecologicalprocedures either in an office or a hospital setting.

As used herein, the term “elevational movement” refers to the verticalup-and-down movement of an upper blade relative to a lower blade of avaginal speculum of the present disclosure.

As used herein, the term “linear” refers to a straight line of material,for example, a straight line of plastic material. A linear supportmember refers to a support member of the present disclosure that is madefrom a straight line of plastic material, having no curves or angles.

As used herein, the term “angulational movement” refers to the angularup-and-down movement of an upper blade relative to a lower blade of avaginal speculum of the present disclosure.

As used herein, the term “lateral movement” refers to the sideways backand forth movement of an upper blade relative to a lower blade of avaginal speculum of the present disclosure.

As used herein, the term “open state” refers to the positioning of anupper blade and a lower blade of a vaginal speculum of the presentdisclosure at a spaced-apart distance. The open state may beaccomplished by elevating a support member that connects the upper bladeand the lower blade together, by angularly moving the upper bladerelative to the lower blade, or by a combination of both.

As used herein, the term “working space” refers to a space createdbetween an upper blade and a lower blade of a speculum of the presentdisclosure. In an embodiment, the working space is created for viewing,examining, and performing surgical procedures on female internal genitalorgans.

As used herein, the term “structural integrity” refers to a featureprovided by a vaginal speculum of the present disclosure prior to,during, and after use. An upper blade and a lower blade of the speculumare designed to withstand applied loads and transfer these applied loadsto various other components of the speculum, while maintaining thestructural integrity of the speculum.

As used herein, the term “fulcrum” refers to a support structure createdby engaging a support member and a support structure of a vaginalspeculum of the present disclosure. The created fulcrum results in theability for an upper blade of the vaginal speculum to angularly movewith relation to a lower blade of the vaginal speculum.

As shown in FIG. 1A and FIG. 1B, a disposable vaginal speculum 100 ofthe present disclosure includes an upper member 120, a linear supportmember 150, and a lower member 130 having a built-in light source 160.The linear support member 150 is engaged to both the upper member 120and the lower member 130, as will be described in detail below. Unlikemetallic speculums, which are not designed for single-use but insteadare meant to be re-used many times with sterilization occurring betweeneach use, the entire speculum 100 of the presently disclosed embodimentsis fabricated from one or more plastics or plastic composites,sterilized when manufactured or packaged, and sufficiently inexpensiveto be discarded after only one use. Sterilization of reusable speculacan be costly and time-consuming. More significantly, if sterilizationis not done properly, blood borne pathogens or other harmful biologicalagents from one patient can survive the sterilization process and betransmitted to another patient. Because the entire speculum 100 of thepresently disclosed embodiments is disposable, there is no need tosterilize the speculum 100 after each use, which greatly reduces thetime and cost associated with such sterilization procedures and preventscross-contamination. Exemplary plastic materials which may be used toconstruct the various components of the speculum 100 include, but arenot limited to, polypropylene, polyester, polyethylene, acrylic,polycarbonate, polyamide, polystyrene, and any composite of more thanone of these plastics. In an embodiment, the upper member 120 and thelower member 130 are fabricated from plastic materials that aresubstantially rigid and capable of transmitting light. For example, theupper member 120 and the lower member 130 may be molded from a colorlesstransparent plastic material such as acrylic plastic or the like.Acrylic plastic is relatively rigid, can be injection molded orextruded, and has excellent light conductive properties most suitablefor use with the speculum 100 of the present disclosure. In anembodiment, the linear support member 150 is fabricated from a differentplastic material than the upper member 120 and the lower member 130. Thelinear support member 150 is fabricated from a rigid, sturdy, plasticmaterial that can handle various load patterns, as will be described indetail below. In an embodiment, the upper member 120 and the lowermember 130 are fabricated from a polycarbonate material. In anembodiment, the linear support member 150 is fabricated from a polyestermaterial. In an embodiment, the linear support member 150 is fabricatedfrom a polyamide material, for example, nylon.

As best illustrated in FIG. 2, the disposable speculum 100 comprises anupper member 120 having an upper blade 122 that terminates in a hingeassembly 125. The hinge assembly 125 receives and transfers loads placedon the upper member 120 and the lower member 130 to various componentsof the speculum 100, as will be described in detail below. The hingeassembly 125 includes an operating mechanism 127 which extends out fromthe hinge assembly 125. As shown in the embodiments depicted in thefigures, the operating mechanism 127 is located on a left-side of theupper blade 122. In another embodiment, the operating mechanism 127 maybe located on a right-side of the upper blade 122. The unique design andlow profile of the hinge assembly 125 enable a user of the speculum 100to have a large unobstructed view of a patient during a gynecologicalprocedure. In an embodiment, the operating mechanism 127 extends out anddown from the upper blade 122 at an angle. Also, a working space 115created when the speculum 100 is in an open state (see FIG. 1B, thespeculum 100 is not shown entirely in the open state in the figures)provides exceptional instrument maneuverability to the user of thespeculum 100. The speculums known in the art often provide a limitedworking space with limited visibility due to a poorly designed hingeassembly.

As shown in FIG. 2 and FIG. 3, the hinge assembly 125 comprises a pairof parallel support beams 129 spaced a distance apart. These parallelsupport beams 129 will interact with the support member 150 to preventhinge slippage when a lateral force is present. The operating mechanism127 interacts with an angulation arm 157 on the support member 150 whichallows a user of the speculum 100 to move the upper blade 122 at variousangles when pressure is applied to the operating mechanism 127 duringuse of the speculum 100. The operating mechanism 127 is formed with anopening 126 for which the angulation arm 157 of the linear supportmember 150 moves through and locks with. The upper blade 122 has athickness, a width and a curve, which prevents failure of the upperblade 122 with the application of pressure or stress, for example duringa gynecological procedure. In an embodiment, the upper blade 122 has arounded distal end.

FIG. 4A and FIG. 4B show the lower member 130 of the speculum 100. Thelower member 130 includes a lower blade 132 and a handle portion 134.The handle portion 134 includes a vertical track 137 for elevationalmovement of the linear support member 150, and a cavity 139 forpositioning of the built-in light source 160 (see FIG. 1A or FIG. 1B).In an embodiment, the track 137 is a carved-out space positioned at asingle side of the handle portion 134. On an outer surface of the handle134 at a distal end of the track 137, there are stop tabs 131. Thesestop tabs 131 encounter a locking tooth 159 on an elevation leg 155 ofthe linear support member 150 (see FIG. 7) and maintain the speculum 100in an open state at various, user-selected distances. Because the lightsource cavity 139 is typically placed in the center of handle 134, thetrack 137 for support member 150 is ideally placed either to the left orthe right of the light source cavity 139. Such placement of the supporttrack 137 will cause translation of the normal vertical stress placedupon top member 120 into a lateral force. A typical speculum will sufferlateral movement of the top blade as a result. This lateral movementinterferes with many physician procedures, can cause patient discomfort,and may lead to a structural failure of the speculum. To eliminate thislateral movement a novel support structure 136 has been added so as toprotrude slightly into the viewing area 115. This support structure 136interacts with a hidden slot 191 in support member 150 (see FIG. 7) tosubstantially eliminate lateral movement. The support structure 136 isshown on the right side of the lower member 130. In an embodiment, thesupport structure 136 and the hidden slot 191 are located on the rightside of the speculum 100. In another embodiment, the support structure136 and the hidden slot 191 are located on both sides of speculum 100.

As shown in the embodiment depicted in FIG. 4B, the handle 134 has atleast one shaped surface so that a user of the speculum 100 may easilygrasp the handle 134. The lower blade 132 has a thickness, a width, anda curve which prevents failure of the blade 132 with the application ofpressure or stress. In an embodiment, the lower blade 132 has a roundeddistal end.

FIG. 5 shows a close-up plan view showing an interior surface 133 of thelower blade 132. The track 137 has a “T-shape,” with a long verticalsection represented by 136 a and a shorter horizontal sectionrepresented by 136 b for accepting the linear support member 150. FIG. 6shows a close-up perspective view of the track 137 in which the supportmember 150 rides in.

FIG. 7 in conjunction with FIG. 8A, FIG. 8B and FIG. 9, show variousviews of the linear support member ISO of the vaginal speculum 100. Thelinear support member 150 has a proximal end 152, a distal end 156 andan elongated body 154 having a “T-shape.” The elongated body 154 rideswithin the track 137. Additionally, the support structure 136 rideswithin the hidden slot 191 to provide additional lateral support. Holes153 of the linear support member 150 attach with the hinge assembly 125of the upper member 120. Key holes 110 interact with the parallelsupport beams 129 of the hinge assembly 125 to prevent slippage andsubsequent failure of the hinge during lateral stresses. The angulationarm 157 and the elevation leg 155 both protrude from a lip 158 of theelongated body 154. The angulation arm 157 passes through the opening126 of the operating mechanism 1.27 of the hinge assembly 125 of theupper member 120 and is held in place with locking teeth on theangulation arm 157. The locking tooth 159 of the elevation leg 155 lockswith the stop tabs 131 on the outer surface of the handle 134.

During a gynecological examination or surgical procedure, it issometimes desirable to illuminate the working area so that a medicalprofessional performing the procedure can properly view the workingarea. Typical specula are not equipped with illumination devices, andnewer speculums that contain light sources generally generate unwantedheat, consume significant power, are tethered to a power source, andproject light in unwanted directions. The power consumed requires wiresto an external power supply which is cumbersome for a medicalpractitioner, creates a potential hazard to a patient, and is a sourceof cross-contamination, as the light source is not easily sterilizedbetween procedures. The unwanted directionality of light will not onlyilluminate the practitioners working space, but also will illuminate thepractitioner and impair the practitioner's vision.

Attempts to overcome the above shortcomings have been problematicthemselves. One known speculum includes a fiber bundle built into thespeculum and an external light source. While this overcomes the heatgeneration and light directionality problem, the problem forcross-contamination still exists. Another known speculum discloses alight bulb built into the speculum handle with a reflector also builtinto the handle. While this overcomes the problem of lightdirectionality, problems related to cross-contamination and heatgeneration still exist. Other speculums disclose a battery operatedhalogen light source built into the handle. This solves thecross-contamination problem, but does not solve the light directionalityproblem and heat problem.

FIG. 10A, FIG. 10B, and FIG. 10C, show an embodiment of the built-inlight source 160 that resides within the handle 134 of the disposable,plastic speculum 100. An outer housing 163 protects internal batteries166, a light emitting diode (LED) 164, and internal components of a tabswitch 165, which is removed to illuminate the LED 164 when illuminationis desired. The LED 164 may produce any desired level of intensity. Forexample, a resistance tab on the built-in light source 160 may be usedto control the intensity of light that the LED 164 can emit. The LED 164has a high power efficiency and consumes relatively little electricalpower with a long lifespan. The LED 164 solves the heat problem becausethe power efficiency of an LED is greatly superior to prior incandescentor laser solutions. The light output from the LED 164 is highlydirectional, emitting light only within about a twenty-degree path. Thisnarrow light path ensures that light is only projected onto the workingarea, and not directly into the practitioner's eyes. The LED 164 isenergy-efficient and can be powered by a single lightweight battery 166or a number of batteries 166. Because the light source 160 is built intothe handle 134 of the disposable speculum 100, the problem ofcross-contamination is eliminated. The built-in light source 160 alsoeliminates cumbersome and potentially dangerous wires extending from thespeculum 100 to an external power supply.

In an embodiment, the LED light source 164 is a white LED.

In an embodiment, single or multiple wavelength LED sources can besubstituted to choose a light wavelength that is uniquely suited tomaterials, chemicals, tissue, or tools used in current or futuregynecological procedures such that these materials, chemicals, tissue ortools will distinctly illuminate when such wavelengths are projected,thus aiding in the practitioner's ability to view and perform aprocedure, aiding in material property changes (such as epoxy hardeningor activating some other specific material property), altering the stateof tissue life, or serving as a contamination neutralizing agent.

In an embodiment, the LED light source 164 is a single wavelength lightemitting diode.

In an embodiment, the LED light source 164 is a multiple wavelengthlight emitting diode.

FIG. 11 shows an embodiment of a light guide 138 having a proximal end138 a and a distal end 138 b. The light guide 1.38 runs from a distalend of the cavity 139 to a distal end of the lower blade 132 on theinterior surface 133 of the lower blade 132 (see FIG. 4A and FIG. 4B).The proximal end 138 a of the light guide 1.38 will transfer lightcoming from the light source 160 through the light guide 138 and out ofthe distal end 138 b. The light guide 138 is contoured to ride on theinterior surface 133 of the lower blade 132. The proximal end 138 a ofthe light guide 138 may include a lens that couples with the lightsource 160 contained in the cavity 139 of the handle 134.

In certain gynecological procedures, it is desirable to remove abnormalcells from the internal and external portions of the cervix. Also,certain gynecological procedures use instruments that produce smoke,which makes it difficult for a medical professional to see a workingspace during the procedure. Therefore, the use of an external vacuumsource during gynecological procedures is common. These external vacuumsources are cumbersome, difficult to manipulate during the procedure,and are a source of cross-contamination, since the vacuum is re-used formany patients.

Existing specula containing both a light guide and a smoke evacuationchannel have typically built the light guide into the lower bladethereof and the smoke evacuation channel into the upper blade thereof.This arrangement significantly detracts from the working space betweenthe two blades that is needed to perform vaginal or uterine procedures.Additionally, an external suction tube must be connected to the upperblade of these existing specula which further complicates and obstructsthe working area for the physician.

FIG. 11 in conjunction with FIG. 4A and FIG. 12 shows the lower member130 of the speculum 100 having a smoke vacuum channel 138 c and thelight guide 138 merged together and positioned within a sunken relief135 of the lower member 130 to create a compact structure. The combinedsmoke channel light guide consists of the light guide 138 with thechannel 138 c for smoke evacuation cut into the side of the light guide138 that comes in contact with the lower blade 132. A tunnel formed bythe channel 138 c is used as a smoke channel. The resulting compactstructure created by merging the smoke vacuum channel 138 c and thelight guide 138 allows for the working space of the speculum 100 to bemaximized. Additionally, an external suction tube may be connected tothe handle 134 of the speculum 100 at an opening 169 instead of at theupper blade 122 of the speculum 100. Connection of the external suctiontube to the lower handle 134 maintains a clear and unobstructed accessto the vaginal area for the physician. Smoke is drawn from the distalend 138 b of the light guide 138 through the channel 138 c that extendsunder the light guide 138 and out the bottom of the speculum handle 134where external suction tubing can be attached.

In an embodiment, debris is drawn from the distal end 138 b of the lightguide 138 through the channel 138 c that extends under the light guide138 and out the bottom of the speculum handle 134 where external suctiontubing can be attached.

In an embodiment, bodily fluids are drawn from the distal end 138 b ofthe light guide 138 through the channel 138 c that extends under thelight guide and out the bottom of the speculum handle 134 where externalsuction tubing can be attached.

The ability of the speculum 100 of the present disclosure to withstandapplied loads is a result of a combination of components of the speculum100, including, but not limited to, the geometry of the hinge assembly125, a support beam 128, the parallel support beams 129, the geometry ofthe upper blade 122 and the lower blade 132, the lateral supportstructure 136 and the hidden slot 191, and the interdependent loadingbetween the various components. In an embodiment, during use, pressureexerted on the operating mechanism 127 is transferred to the hingeassembly 125, the mechanical holes 153, and down the elongated body 154of the linear support member 150. As shown clearly in FIG. 3 and FIG. 8,the operating mechanism 127 is an extension of the hinge assembly 125,extending outwards and downwards at an angle. This extension design ofthe operating mechanism 127 imparts asymmetrical loads on the plasticlinear support member 150 and will create lateral movement on the distalend of the upper blade 122. To prevent lateral movement, the novelfeatures of the lateral support structure 136 and the hidden slot 191have been added. For example, the operating mechanism 127 is capable ofabsorbing some of the initial load that a user imparts on the speculum100, such that the load is felt asymmetrically at the two support holes153 of linear support member 150. These asymmetric loads placed on thelinear support member 150 are directed in both a downward and forwarddirection. The asymmetrical forward loads in turn result in a lateralforce on the elongated body 156 of the linear support member 150. In atypical speculum this lateral force will cause twisting of the elongatedbody of the linear support member thereof, and may cause unwantedmovement of the speculum blades or hinge failure. In this embodiment,the lateral support structure 136 and the hidden slot 191 absorb theasymmetrical forward forces and in turn substantially eliminate twistingof the elongated body 156 of the linear support member 150. Thisreduction in twisting load at the linear support member 150 reduces thetendency of the linear support member 150 to twist and permits the useof a plastic linear support member 150.

During use of the speculum 100, for example during a gynecologicalprocedure, the speculum 100 is inserted into a patient's vagina. Thevaginal walls in turn exert a pressure, or load, on the upper blade 122and the lower blade 132 of the speculum 100. The upper blade 122 and thelower blade 132 are capable of transferring this load to the supportmember 150 and the operating mechanism 127 because of the unique designof the lateral support structure 136 of the lower member 130 of thespeculum 100. The support structure 136 is capable of supporting thelateral load and distributes the vertical load equally down both thelinear support member 150 and the operating mechanism 127. This resultsin a great deal of holding power in a relatively small area withoutlateral top blade movement or top blade hinge failure.

The upper blade 122 and the lower blade 132 have a curved shape whichincreases the stiffness and strength of the blades. The stiffnessimparted on the curved blades enables the blades to support the appliedload along an entire length of the blades, without the need foradditional strengthening structures within the blades. The proximal end152 of the linear support member 150 and the parallel hidden slot 191and track 137 help prevent failure of the speculum 100 due to asymmetricloading on the blades that would cause the speculum 100 to twistrelative to the handle's 134 axis. The design of the speculum 100prevents twisting.

To operate the speculum 100 of the present disclosure during agynecological procedure, the upper blade 122 and the lower blade 132 areinserted into a vagina of a patient in a closed position. Closedposition can refer to complete closure, where the upper blade 122engages the lower blade 132, or can refer to partial closure, where theupper blade 122 and the lower blade 132 are partially separated.Thereupon, the linear support member 150 is moved upwardly by pressingon the elevation leg 155 until a desired degree of opening has beenattained. The locking tooth 159 of the elevation leg 155 locks with thestop tabs 131 on the outer surface of the handle 134. In an embodiment,when the desired degree of opening has been attained, the operating arm127 of the operating mechanism 125 is pressed spreading the upper blade122 and the lower blade 132 apart at an angle. The locking teeth on theangulation arm 157 lock at the opening 126 of the operating mechanism125, resulting in the speculum 100 being held in the open position. Thelight source 160 may be turned on to illuminate a surgical orexamination site. The pull tab 165 of the light source 160 is removed,resulting in the LED 164 illuminating. At the end of the procedure, thepull tab 165 may be inserted again to turn the LED 16 off. It is to beunderstood that a speculum 100 of the present disclosure may befabricated in various sizes, such that the proper sized speculum 100 canbe used for each patient. The speculum 100 may also be fabricated fromvarious strength plastic materials based on the desired use of thespeculum 100, as long as the structural integrity of the speculum 100remains. For example, for a routine PAP test, a lower strength speculum100 may be used as compared to a speculum 100 for use during vaginalhysterectomy.

In an embodiment, a speculum 100 is provided that includes an adjustableupper blade 122 and an adjustable lower blade 132 capable of expandingduring use of the speculum 100. Means for providing adjustable bladesinclude, but are not limited to, the use of laterally adjusting bladesthat expand the width of the blades and the use of longitudinallyadjustable blades that expand the length of the blades. The adjustableblades can be withdrawn partially or completely.

In an embodiment, a speculum 100 is provided that includes heating meansfor warming the upper blade 122 or the lower blade 132. The extra warmthprovided by the heating means enhances patient comfort and helps torelax the vaginal area. Means for heating the blades include, but arenot limited to, the use of heating coils within a hollowed out space ofthe blades, the use of powdered chemicals within a hollowed out space ofthe blades that are able to oxidize when exposed to air. In anembodiment, a speculum 100 includes heating coils on the upper blade 122and the lower blade 132 for bringing the temperature of the blades tobody temperature. In an embodiment, the heating coils can be powered bythe batteries 166 used in the built-in light source 160. In anembodiment, the heating coils can be powered by a different battery.

In an embodiment, a speculum 100 is provided that includes a distallymounted camera chip for real-time data capture and/or viewing of amedical procedure. The camera chip can store and/or capture data, andcommunicate with computer software to analyze the data. Data captured onthe camera chip can be analyzed for cellular and visual abnormalities ofthe vulva, vagina and cervix.

In an embodiment, a speculum 100 is provided that includes a pressuregauge, so that the pressure being applied from the speculum 100 to thevagina, or from the vagina to the speculum 100, can be monitored, aswell as the tightness of the vaginal canal. The pressure gauge may besimilar to a strain gauge and may be built into the speculum 100, forexample, at the hinge assembly 125.

In an embodiment, a speculum 100 is provided that includes a pH teststrip or a pH meter, for the fast and accurate determination of theacidity level of the vaginal canal being examined. The pH strip or pHmeter would be exposed to vaginal secretions to access the pH at anypoint in a gynecological or surgical procedure.

In an embodiment, a speculum 100 is provided that includes means forlubricating either or both of the upper blade 122 and the lower blade132. The lubricated blades make it easy for the speculum 100 to beinserted into a vaginal cavity of a patient, while providing a moistwork environment during a gynecological or surgical procedure.

In an embodiment, a body of the upper blade 122 and/or the lower blade132 has a hollowed-out space for passage of a lubricating jelly, as wellas holes at a surface for release of the lubricating jelly.

In an embodiment, the speculum 100 may come pre-packaged with an amountof lubricating jelly within the hollowed-out space of the blade. Thelubricating jelly is released through the holes present at the bladessurface, for example, by pushing a button on the handle 134. In anembodiment, the speculum 100 may include a port that can attach to aluer-lock syringe having the lubricating jelly, for passage of thelubricating jelly into the blades.

A method for dilating a vagina includes providing a disposable vaginalspeculum. The speculum has an upper member containing an upper blade, alower member containing a lower blade and including one or more lateralsupport beams that extend downward from an interior side of the lowerblade, and a linear support member that connects the upper member havingthe upper blade to the lower member containing the lower blade, suchthat the linear support member engages the lateral support beam or beamsand engages a rotational operating mechanism extending off the upperblade and a linear operating mechanism extending from the lower member.The linear support member is vertically moveable within a trackpositioned at a single side of a handle portion of the lower member. Themethod for dilating a vagina further includes inserting the upper bladeand the lower blade of the speculum into an opening of the vagina, andcreating a working space between the upper blade and the lower blade,thus dilating the vagina.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art which arealso intended to be encompassed by the following claims.

1. A speculum comprising: an upper member comprising an upper bladewhich has a distal end and a proximal end; a lower member comprising alower blade having a distal end and a proximal end and having a rightside and a left side when viewed from the proximal end of the lowerblade, the lower blade comprising a support structure positioned at theproximal end of the lower blade and which extends vertically on one ofthe right side or the left side of the lower blade, and a handle portionextending downwardly from the proximal end of the lower blade anddefining a vertical track; and a linear support member having a proximalend pivotally connected to the proximal end of the upper blade, a distalend, and an elongated body between the proximal end and the distal endof the linear support member, wherein the elongated body of the linearsupport member slidably engages the vertical track of the handleportion, and wherein the linear support member is formed with a hiddenslot which slidably receives the support structure of the lower blade.2. The speculum of claim 1, wherein the vertical track defined by thehandle portion is positioned at a location corresponding to the otherone of the right side or the left side of the lower blade.
 3. Thespeculum of claim 1, wherein the upper member further comprises a hingeassembly positioned at the proximal end of the upper blade, the hingeassembly comprising a pair of support beams protruding laterally onopposite sides of the upper blade, and wherein the proximal end of thelinear support member is formed with a pair of holes which pivotally andrespectively receive the support beams of the hinge assembly.
 4. Thespeculum of claim 3, wherein the hinge assembly of the upper memberfurther comprises an operating mechanism which extends outwardly and ina downward direction from the upper blade at an angle from the upperblade of the upper member.
 5. The speculum of claim 4, wherein thelinear support member comprises an angulation arm that extendsrearwardly from the elongated body and which has locking teeth, andwherein the operating mechanism of the hinge assembly is formed with anopening, the angulation arm extending into the opening of the operatingmechanism and the locking teeth of the angulation arm releasablyengaging a portion of the operating mechanism defining the opening tothereby secure the operating mechanism to the angulation arm.
 6. Thespeculum of claim 1, wherein the vertical track defined in the handleportion of the lower member and the elongated body of the linear supportmember are T-shaped.
 7. The speculum of claim 1, wherein the handleportion of the lower member is formed with a plurality of stop tabsdownwardly from a distal end of the vertical track, and the linearsupport member comprises a locking tooth extending downwardly andforwardly angled from the distal end of the linear support member andwhich releasably engages one of the stop tabs of the handle member tolock the linear support member at a vertical position.
 8. The speculumof claim 7, wherein the linear support member further comprises anelevation leg which extends upwardly from the distal end of the linearsupport member in a manner spaced apart from the elongated body, theelevation leg being pressed by a user to move the linear support memberupwardly so that the locking tooth of the linear support memberreleasably engages another one of the stop tabs of the handle member. 9.The speculum of claim 1, wherein each of the upper member, the lowermember, and the linear support member is fabricated from a plasticmaterial.
 10. The speculum of claim 9, wherein the plastic material isselected from group consisting of polypropylene, polyester,polyethylene, acrylic, polycarbonate, polyamide, polystyrene, and acomposite thereof.
 11. The speculum of claim 9, wherein the linearsupport member is fabricated from a different plastic material than theupper member and the lower member.
 12. The speculum of claim 11, whereinthe linear support member is fabricated from a polyester material or apolyamide material, and each of the upper member and the lower member isfabricated from a polycarbonate material.
 13. The speculum of claim 1,wherein the handle portion of the lower member is formed with a cavity,and the speculum further comprises a light source disposed in the cavityand which selectively projects light between the upper blade and thelower blade.
 14. The speculum of claim 13, wherein the cavity is formedapproximately in the center of the handle portion and the vertical trackis positioned to the left or right of the cavity when viewed from theproximal end of the lower blade.
 15. The speculum of claim 13, whereinthe light source comprises at least a pair of batteries, a lightemitting diode, and a tab switch which is removed by a user so that thebatteries power the light emitting diode to illuminate.
 16. The speculumof claim 15, further comprising a light guide having a proximal end anda distal end and finning from a distal end of the cavity to the distalend of the lower blade on an interior surface of the lower blade, theproximal end of the light guide transferring light from the light sourcethrough the light guide and out of the distal end of the light guide.17. The speculum of claim 16, wherein the light guide defines a smokevacuum channel in a bottom side thereof.
 18. The speculum of claim 17,wherein the lower member is formed with a sunken relief, and the lightguide with the smoke vacuum channel formed therein is positioned withinthe sunken relief.
 19. A method for dilating a vagina comprising: (a)providing a disposable vaginal speculum comprising an upper membercomprising an upper blade which has a distal end and a proximal end; alower member comprising a lower blade having a distal end and a proximalend and having a right side and a left side when viewed from theproximal end of the lower blade, the lower blade comprising a supportstructure positioned at the proximal end of the lower blade and whichextends vertically on one of the right side or the left side of thelower blade, and a handle portion extending downwardly from the proximalend of the lower blade and defining a vertical track; and a linearsupport member having a proximal end pivotally connected to the proximalend of the upper blade, a distal end, and an elongated body between theproximal end and the distal end of the linear support member, whereinthe elongated body of the linear support member slidably engages thevertical track of the handle portion, and wherein the linear supportmember is formed with a hidden slot which slidably receives the supportstructure of the lower blade; (b) inserting the upper blade and thelower blade of the speculum into an opening of the vagina; and (c)creating a working space between the upper blade and the lower blade,thus dilating the vagina.
 20. The method of claim 19, wherein creatingthe working space between the upper blade and the lower blade comprisesat least one of moving the linear support member of the speculum in anupward direction within the vertical track of the lower member such thatthe support structure of the lower blade slides along the hidden slot ofthe linear support member, and spreading the upper blade and the lowerblade apart at an angle by pivoting the upper blade of the upper memberabout the proximal end of the linear support member.
 21. The method ofclaim 20, wherein: the upper member further comprises a hinge assemblypositioned at the proximal end of the upper blade, the hinge assemblycomprising a pair of support beams protruding laterally on oppositesides of the upper blade, and the proximal end of the linear supportmember is formed with a pair of holes which pivotally and respectivelyreceive the support beams of the hinge assembly. the hinge assembly ofthe upper member further comprises an operating mechanism which extendsoutwardly and in a downward direction from the upper blade at an anglefrom the upper blade of the upper member; and pivoting the upper bladeand the lower blade apart comprises pressing against the operatingmechanism such that the support beams of the hinge assembly pivot withinthe holes of the linear support member and the upper blade of the uppermember pivots about the proximal end of the linear support member.